Many of our pharmaceutical clients, both large and small, are regularly faced with the challenge of conducting multiple clinical trials to study various aspects of a particular drug or device on the path to commercialization.
For example, one clinical trial might assess the safety and efficacy of a single drug in a specific patient population, dosing regimen, or indication. At the same time, that product is likely to be investigated in alternate trials to be approved for other populations, regimens, or indications.
As the clinical development process advances study by study, it can be difficult for companies to take advantage of opportunities for meaningful and cost-saving designs across an entire drug program.
As an expert provider of independent committee services, ACI has gained a unique clinical and operational vantage point to see these missed connections ahead of time. We’ve found the potential for significant efficiencies and cost savings through a “program-wide” approach to expert committees.
Recently, one of our global pharmaceutical clients was able to achieve a savings of over $2 million through the design and use of a specialized Program-Wide Endpoint Adjudication Committee. This single committee was able to efficiently oversee adjudication of events across three clinical trials. While each trial had a unique protocol, process, and set of endpoints, the similarities related to the drug being tested and overall study timelines, were leveraged to create one committee capable of expertly adjudicating all three studies.
Program-Wide Committee benefits:
• Significant savings in overall time and cost (especially in committee start-up)
• Meeting, communication, and project management efficiencies
• Improved committee knowledge / awareness of overall product development
• Programming efficiencies
By using this program-wide approach, our clients have been able to avoid the expense and headache of having too many committees, while gaining the efficiencies of a simplified startup, maintenance, and closeout. We’ve found that a well-designed Program-Wide Committee solution can reduce startup and closeout expenses by 25 to 75 percent and overall committee costs by as much as 15 to 30 percent.
While drug and device development companies will continue to face increasing complexity on a product’s path to market, there is a significant opportunity right now to implement a more efficient and effective approach. ACI Clinical can be an expert ally in this effort to ease the burden with unique, customized solutions that provide meaningful and cost-saving improvements.
Program-Wide solutions can be applied to the following ACI services:
• Endpoint Adjudication Committees
• Data Monitoring Committees
• Data conversions